Gallium Citrate Ga 67 (Systemic)


VA CLASSIFICATION
Primary: DX201

Commonly used brand name(s): Neoscan.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Diagnostic aid, radioactive (neoplastic disease; focal inflammatory lesions)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Neoplastic disease (diagnosis)—Gallium citrate Ga 67 is indicated to demonstrate the presence and extent of lymphoma, bronchogenic carcinoma, [acute myelocytic leukemia] , [chronic myelocytic leukemia] , [hepatoma] , and [bone sarcoma] . May also be useful in the detection of [epithelial, head, and neck carcinoma] ; [malignant melanoma] ; [malignant fibrous histiocytoma] ; and [testicular tumors] . {01} {08} {09} {12} {19} {20} {21} {23} {33} {39}

Inflammatory lesions, focal (diagnosis)—Gallium citrate Ga 67 is indicated for the localization of focal inflammatory lesions, such as abscess, osteomyelitis, pneumonia, pyelonephritis, and granulomatous diseases (sarcoidosis). May also be useful in the detection of active tuberculosis; and for assessing the activity of the inflammatory process in certain interstitial pulmonary diseases, including sarcoidosis and fibrosing alveolitis. {01} {02} {20} {23} {28} {35}
—In combination with thallous chloride Tl 201 imaging, gallium citrate Ga 67 imaging may be useful in the diagnosis of myocardial sarcoidosis and in predicting the response to corticosteroid therapy. {27}

[Immunodeficiency syndrome, acquired, related disorders of (diagnosis)]1—Gallium citrate Ga 67 is useful in the diagnosis and monitoring of Pneumocystis carinii pneumonia, tuberculosis, and other infections in acquired immunodeficiency syndrome (AIDS) patients. {01} {15} {16} {17} {30}

[Fever, unknown origin, source of (diagnosis)]1—Gallium citrate Ga 67 is useful as a diagnostic screening test in cases of prolonged fever, when physical examination, laboratory tests, and other imaging studies have failed to disclose the source of the fever. {13} {29} {31} {32} {39}

—In the absence of pre-existing symptoms, a positive uptake of gallium citrate Ga 67 justifies additional testing for potential disease. {01} {23} {38}

1 Not included in Canadian product labeling.



Physical Properties

Nuclear data {01} {10}:



Radionu-
clide
(half-life)
Decay
constant
Mode
of
decay
Principal
photon
emissions
(keV)
Mean
number of
emissions/
disintegration
(³0.01)
Ga 67
(78.26 hr)
0.00886 hr-1
Electron capture
Gamma-3
(93.3)
0.37
      Gamma-4
(184.6)
0.20
      Gamma-5
(300.2)
0.17


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Diagnosis of neoplastic disease and

Diagnosis of inflammatory lesions—The exact mechanism of action is unknown, but gallium citrate Ga 67 has been found to concentrate in certain viable primary and metastatic tumors as well as focal sites of inflammation. Studies of Ga 67 accumulation in acute inflammatory lesions suggest that a number of factors are involved in the accumulation and retention of Ga 67 at the site of inflammation. Adequate blood supply is essential for delivery of Ga 67 to the lesion. Ga 67, mainly in the form of transferrin-Ga-67 complex, is delivered to the lesion through capillaries with increased permeability. Some Ga 67 is taken up by the leukocytes and bacteria, if present at the site of inflammation. {01} {06} {23} {39}

Distribution:

Rapidly distributed throughout body; concentrating first in tumors and sites of infection, and renal cortex. Maximum concentration shifts to bone (including marrow) and lymph nodes after the first day, and to liver and spleen after the first week. {23} {38}

Protein binding:

High (mainly to plasma transferrin; to a lesser extent to albumins and globulins {09}).

Half-life:

Biological—Approximately 2 to 3 weeks. {01} {02} {09}

Radiation dosimetry:
{03}{10}{11}{25}

Estimated absorbed radiation dose *
Organ
mGy/MBq
rad/mCi
Bone surfaces
0.59
2.18
Intestine wall (lower)
0.20
0.74
Red marrow
0.19
0.70
Spleen
0.15
0.55
Adrenals
0.14
0.52
Liver
0.12
0.44
Intestine wall (upper)
0.12
0.44
Kidneys
0.11
0.41
Pancreas
0.083
0.31
Ovaries
0.082
0.30
Bladder wall
0.081
0.30
Uterus
0.079
0.29
Stomach wall
0.072
0.27
Lungs
0.065
0.24
Breast
0.062
0.23
Small intestine
0.059
0.22
Testes
0.057
0.21
Thyroid
0.056
0.21
Other tissue
0.063
0.23
Effective dose: 0.12 mSv/MBq (0.44 rem/mCi)
* For adults; intravenous injection.

Elimination:


Slow {01} {11} {23} {38}


Primary—
        Renal (26% of the administered dose of which 10 to 15% is eliminated within 24 hours).



Secondary—
        Fecal (10% within the first week). Fecal excretion becomes primary route of excretion after the first 24 hours. {11}

Note: Bowel radioactivity may interfere with the interpretation of abdominal scans. To cleanse the bowel prior to imaging, laxatives and/or enemas are recommended on the day of gallium citrate Ga 67 administration and/or subsequent days prior to imaging. Imaging is usually done 48 to 72 hours after administration of the radiotracer. {11} {20} {23} {39}





Precautions to Consider

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of gallium citrate Ga 67 have not been performed. {38}

Pregnancy/Reproduction

Pregnancy—
Gallium citrate Ga 67 crosses the placenta. Adequate and well-controlled studies have not been done in humans.

The possibility of pregnancy should be assessed in women of child-bearing potential. Clinical situations exist where the benefit to the patient and fetus, based on information derived from radiopharmaceutical use, outweighs the risks from fetal exposure to radiation. In these situations, the physician should use discretion and reduce the radiopharmaceutical dose to the lowest possible amount. {24}

Studies have not been done in animals.

FDA Pregnancy Category C. {23} {38}

Breast-feeding

Gallium citrate Ga 67 is excreted in breast milk. It has been recommended that nursing be resumed, after administration of a radiopharmaceutical, when the infant's ingested effective dose equivalent (EDE) is below 1 mSv (100 mrem). A method to calculate the EDE has been proposed based on the effective half-life of the radionuclide, the activity administered to the mother, the fraction of administered activity ingested by the infant, and the total body effective dose equivalent to the newborn infant per unit of activity ingested. According to this method, it has been estimated that, for gallium citrate Ga 67, the time to reduce the EDE to the infant to below 1 mSv (100 mrem) is approximately 3 weeks after administration to the mother. Because of the difficulty of maintaining the maternal milk supply for such an extended period of time, complete cessation of nursing is usually recommended. {18}

Pediatrics

There have been no specific studies evaluating safety and efficacy of gallium citrate Ga 67 in children. When this radiopharmaceutical is used in children, the diagnostic benefit should be judged to outweigh the potential risk of radiation. {24}

Caution is recommended when using preparations that contain benzyl alcohol as preservative in neonates, particularly infants born prematurely. {01} {20}


Geriatrics


Appropriate studies on the relationship of age to the effects of gallium citrate Ga 67 have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Drug interactions and/or related problems
See Diagnostic interference.

Diagnostic interference
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With results of this test

Due to other medications
Antineoplastics, which cause an elevation of serum iron, such as:
Cytarabine
Fluorouracil
Methotrexate or
Iron    (concurrent use may result in more unbound Ga 67, thus increasing renal excretion and bone uptake of Ga 67, possibly by elevating serum iron, which in turn may displace Ga 67 from plasma protein-binding sites; tumor or abscess localization of gallium citrate Ga 67 is decreased {05} {11} {20})


Calcium gluconate, parenteral    (soft tissue accumulation of gallium citrate Ga 67 may occur as a result of extravasated calcium gluconate {05} {39})


COPP chemotherapy    (thymic uptake of gallium citrate Ga 67 may occur during or after cyclophosphamide-vincristine-procarbazine-prednisone [COPP] chemotherapy {39} {41})


Corticosteroids, glucocorticoid    (concurrent use may decrease gallium citrate Ga 67 uptake by brain tumor or abscess because of reduced peritumor edema caused by the steroid {05} {11})

    (thymic uptake of gallium citrate Ga 67 may occur with concurrent use of prednisone {05} {39})


Gallium nitrate    (gallium nitrate competes with gallium citrate Ga 67 for plasma protein binding sites, resulting in reduced tumor or abscess uptake and increased skeletal uptake, increased renal excretion, and reduced liver uptake of gallium citrate Ga 67 {11} {26})


Iron dextran    (abscess-to-muscle ratio may be increased when iron dextran is given 24 hours after the injection of gallium citrate Ga 67, but may be decreased if given before or concurrently with it; this effect is probably due to a displacement of Ga 67 from plasma protein–binding sites by the iron, which results in increased elimination of the radiopharmaceutical {05} {11})


Mechlorethamine or
Vincristine    (concurrent use may decrease whole body retention and increase bone deposition and urinary excretion of gallium citrate Ga 67 {05} {07} {11} {22})


Due to medical problems or conditions
Cardiotoxicity, doxorubicin-induced    (doxorubicin-induced cardiotoxicity may enhance myocardial uptake of gallium citrate Ga 67 {34} {37})


Gynecomastia or hyperprolactinemia, diethylstilbestrol-, imipramine-, metoclopramide-, oral contraceptive-, phenothiazine-, or reserpine-induced    (possible localization of gallium citrate Ga 67 in breast [females and males] {05} {11} {34} {36})


Lymphadenopathy, phenytoin-induced    (false positive images that resemble true lymphoma may occur since phenytoin has been associated with the development of local or generalized lymphadenopathy; condition should be differentiated from other types of lymph node pathology and the patient observed for an extended period of time {05} {11})


Nephritis, drug-induced    (interstitial nephritis induced by drugs [e.g., allopurinol, cephalosporins, erythromycin, furosemide, gold compounds, nonsteroidal anti-inflammatory drugs, pentamidine, phenobarbital, rifampin, sulfonamides, thiazide diuretics] may result in kidney uptake of gallium citrate Ga 67 that resembles that observed with other inflammatory kidney disease and possibly may be mistaken for glomerulonephritis, pyelonephritis, or the nephrotoxic syndrome {05} {11} {40})


Pseudomembranous colitis, antibiotic-induced    (inflammation of the colon induced by antibiotics or other drugs may result in colonic uptake of gallium citrate Ga 67 that resembles that observed with other inflammatory bowel diseases {11} {34})


Pulmonary disease, amiodarone-, bleomycin-, busulfan-, combination chemotherapeutic agent–, or nitrofurantoin-induced    (pulmonary interstitial pneumonitis and/or fibrosis induced by therapy with these medications may result in diffuse pulmonary localization of gallium citrate Ga 67 that resembles that observed with other diffuse pulmonary diseases not related to drug therapy {05} {11} {34})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).

See also Diagnostic interference.

Risk-benefit must be considered when the following medical problem exists
Sensitivity to the radiopharmaceutical preparation


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Fast heartbeat
    
nausea or vomiting
    
skin rash, hives, or itching
{01}{23}




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Radiopharmaceuticals (Diagnostic)

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Action in the body: Concentration of radioactivity in certain tumors and sites of inflammation allows images to be obtained

Small amounts of radioactivity used in diagnosis; radiation received is low and considered safe

Before having this test
»   Conditions affecting use, especially:
Sensitivity to the radiopharmaceutical preparation

Pregnancy—Crosses the placenta; risk to fetus from radiation exposure as opposed to benefit derived from use should be considered





Breast-feeding—Excreted in breast milk; cessation of nursing recommended because of risk to infant from radiation exposure





Use in children—Risk from radiation exposure as opposed to benefit derived from use should be considered



Preparation for this test:
Special preparatory instructions may apply; laxatives or enemas may be prescribed



Precautions after having this test:
No special precautions



Side/adverse effects
Signs of potential side effects, especially fast heartbeat; nausea or vomiting; or skin rash, hives, or itching


General Dosing Information
Radiopharmaceuticals are to be administered only by or under the supervision of physicians who have had extensive training in the safe use and handling of radioactive materials and who are authorized by the appropriate Federal or State agency, if required or, outside the U.S., the appropriate authority.

Gallium citrate Ga 67 is to be administered intravenously only. {01} {23}

Imaging is usually done 48 to 72 hours after administration of the radiotracer. {11} {20}

Abnormal gallium citrate Ga 67 concentration usually implies the existence of underlying pathology, but further diagnostic studies may be required to distinguish benign from malignant lesions. {01} {23} {38}

To cleanse the bowel of radioactive material and minimize the possibility of false-positive test results, laxatives and/or enemas may be given daily until final images are obtained. {11} {23}

Safety considerations for handling this radiopharmaceutical
Improper handling of this radiopharmaceutical may cause radioactive contamination. Guidelines for handling radioactive material have been prepared by scientific, professional, state, federal, and international bodies and are available to the specially qualified and authorized users who have access to radiopharmaceuticals. {42}


Parenteral Dosage Forms

GALLIUM CITRATE Ga 67 INJECTION USP

Usual adult and adolescent administered activity
Diagnostic aid, radioactive (neoplastic); and
Diagnostic aid, radioactive (focal inflammatory lesions)
Intravenous, 74 to 185 megabecquerels (2 to 5 millicuries). {38}

Note: In patients with known tumors, doses of 370 megabecquerels (10 millicuries) are used, to facilitate tomography (SPECT) and delayed imaging (>96 hours). {20}



Usual pediatric administered activity
Dosage must be individualized by physician.

Usual geriatric administered activity
See Usual adult and adolescent administered activity .

Strength(s) usually available
U.S.—


74 megabecquerels (2 millicuries) ± 10% of gallium Ga 67 per mL at time of calibration (Rx) [Neoscan][Generic]

Canada—


As per labeling of supplier[Generic]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Note: Caution—Radioactive material.




Revised: 08/02/1994



References
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